FDA Approves New Melanoma Treatment
The Food and Drug Administration has approved a cancer therapy for advanced melanoma, NBC News reports.
What’s going on: “The treatment, called Amtagvi, from Iovance Biotherapeutics, is for metastatic melanoma patients who have already tried and failed other drugs. It’s known as TIL therapy and involves boosting the number of immune cells inside tumors, harnessing their power to fight the cancer.”
- The news marks the first time a cellular therapy has been green-lighted to treat solid tumors.
- While this approval is only for melanoma—the skin cancer with the highest mortality rate—experts believe the therapy “holds promise for treating other solid tumors, which account for 90% of all cancers.”
- The company is now conducting a larger phase 3 trial to confirm the drug’s benefits, according to NBC News.
Why it’s important: “It is our hope that future iterations of TIL therapy will be important for lung cancer, colon cancer, head and neck cancer, bladder cancer and many other cancer types,” said Dr. Patrick Hwu, chief executive of the Moffitt Cancer Center in Tampa, Florida, who was involved in Amtagvi’s clinical trials of TIL therapy.
- TIL therapy is similar to CAR T-cell therapy, a cell-based treatment in which a patient’s own T-cells are removed from the blood, “programmed” in a lab to root out and fight cancer cells and then put back into the body. In TIL therapy, the cells used are taken from a solid tumor.
Not risk-free: “Putting billions of cells back into the body is not entirely risk-free, however … It’s possible that the body’s immune system could overreact in what’s known as a cytokine storm, which can cause flu-like symptoms, low blood pressure and organ damage.”
- But in clinical trial data for Amtagvi, tumors shrank in about a third of the patients who received the therapy.